In his position as Director and Head of Sample Management, Dr. Green is faced with a number of challenges, including AstraZeneca's transition from their research and development center in northwestern England, to a new research center to be built in Cambridge. The greater challenge going forward is, from Dr. Green's perspective, maximizing value from the biospecimens in the collection. This involves, among other issues, closing the gap in inventory management methods between the small molecule world and the world of biospecimens.
In this interview, Clive shares his perspective on biobanking, as it compares to managing a small molecule inventory, and challenges in the biospecimen supply chain.
Question: Thanks, Dr. Green, for speaking with us today. Your presentation at ISBER included a discussion of how biospecimens drive value, and about logistics and rapid access to specimens. Can you elaborate on this?
Answer: Rapid access to samples is essential in understanding human target validation earlier in research and optimizing the clinical trial process. Consequently, increasing the speed of operations is a primary focus among my colleagues both from clinical disciplines and biobanking, and this means just-in-time processing of samples by the biobank. Speeding up drug development means responding faster to what is happening in the clinic and getting samples to researchers far quicker than we have in the past. There is a mindset that it takes many years to develop a new therapy. But companies are challenging this mindset—aiming to ensure the development process does not consume more time than is necessary, in order to deliver new medicines to patients faster. We need to be faster in the clinic and more agile with the samples. We believe that it should take no longer than 48 hours from a researcher requesting a sample to having the order processed and dispatched to them. In the small molecule arena, which we also manage, our service level agreements are to process more than 95 percent of all requests within 24 hours.
Question: Can you talk more on the differences between supporting small molecule research versus biospecimen-based research?
Answer: There are many similarities—receiving, laboratory processing, storage, retrieval and reformatting, global logistics—there is a lot of overlap and many of the same challenges. But there are also differences: small molecule research compounds have no intrinsic link to a patient. They originate in internal chemistry campaigns or commercial acquisitions, so the methods for controlling use are amenable to simple IT applications. With biospecimens, consent can differ between clinical studies, and ethical perspectives can be translated into different legislation across territories, which also continually evolve. And sample quality is not easily or routinely measured throughout the sample lifetime.
The utilization rate between the two sample types also offers an insight into the difference. For instance, AstraZeneca added about 210,000 biospecimens to inventory in 2014, with about 60,000 shipped out of the collection for use in research. In the same year, the company added about 45,000 compounds to the small molecule inventory, with 1.15 million used for research. Whilst we should expect to see a difference in the utilization rate due to the very different roles the sample types play in research, the experience from small molecule research helps us to understand that greater utilization of biospecimens should be possible. Colleagues in biobanking have discussed achieving a 1:1 utilization rate–the same numbers of samples being added to an inventory as those being requested. This is a realistic medium-term goal that will provide greater value through scientific research.
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